Decision-Making Tool for Blood Thinners

(DDInteract Trial)

Recruiting at 2 trial locations

Overseen By Ainhoa Gomez Lumbreras, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must be taking: Oral anticoagulants

Disqualifiers: Non-English/Spanish speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

3691 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new decision-making tool called DDInteract, designed to help doctors and patients understand the risks and benefits of taking blood thinners with other medications. The tool aims to simplify choosing the best treatment plan by illustrating possible outcomes and drug interaction risks. The trial involves two groups: one using the tool and the other not. Patients taking more than one prescription blood thinner, such as warfarin or apixaban, might be suitable candidates for this trial. As an unphased trial, it offers patients an opportunity to contribute to innovative research that could enhance treatment decisions for many.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It focuses on helping you and your doctor make informed decisions about drug interactions with blood thinners.

What prior data suggests that the DDInteract tool is safe for use in anticoagulated patients?

Research has shown that DDInteract helps patients and doctors make safer choices about using blood thinners. Clinics use this tool to understand and lower the risk of drug interactions, particularly the risk of bleeding when taking multiple medications.

Studies have found that DDInteract improves conversations between doctors and patients about these risks. While DDInteract itself causes no side effects, it helps identify and manage potential problems from drug interactions. Research suggests it is a safe and useful addition to medical care for patients on blood thinners. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DDInteract tool because it offers a novel way to manage blood thinners by evaluating the risk of drug-drug interactions. Unlike current options, which mainly focus on prescribing the right anticoagulant based on general guidelines, DDInteract personalizes treatment by assessing potential interactions specific to each patient's medication regimen. This tool empowers clinicians with more precise data, potentially reducing complications from interactions, and improving patient safety.

What evidence suggests that the DDInteract tool is effective for decision-making in anticoagulated patients?

Research shows that DDInteract, which participants in this trial may encounter, is designed to assist patients and doctors in making better choices about blood thinners. Studies suggest this tool might reduce the risk of harmful drug interactions, which occur when medicines negatively affect each other, for those taking blood thinners. It uses visuals to clarify possible risks and benefits. Early findings indicate that DDInteract can enhance discussions between patients and doctors when there's a risk of bleeding due to drug interactions. Overall, DDInteract aims to make treatment safer and more personalized by promoting shared decision-making. ^{1 2 3 4 5}

Who Is on the Research Team?

Daniel C Malone, PhD

Principal Investigator

College of Pharmacy. University of Utah

Are You a Good Fit for This Trial?

This trial is for adults over 21 who are prescribed oral anticoagulants like warfarin or apixaban and take more than one medication. It's not suitable for those who can't communicate in English or Spanish.

Inclusion Criteria

I am 21 years old or older.

I am taking a prescribed oral blood thinner.

Exclusion Criteria

I cannot speak English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline period to assess initial risk of gastrointestinal bleeding before DDInteract implementation

12 months

Implementation

Implementation of DDInteract tool in clinics to evaluate its effectiveness in mitigating drug interactions

18 months

Follow-up

Participants are monitored for safety and effectiveness after the implementation of DDInteract

6 months

What Are the Treatments Tested in This Trial?

Interventions

• DDInteract

Trial Overview The study tests a shared-decision making tool, DDInteract, designed to manage drug interactions in patients taking blood thinners. It integrates with electronic health records to assess risks and help doctors and patients make informed decisions together.

How Is the Trial Designed?

Group I: Exposure to DDInteract tool in anticoagulated patients Experimental Treatment 1 Intervention

This population will consist in outpatient clinics who treat oral anticoagulated patients where DDInteract has been implemented. This intervention is referred to as DDInteract tool exposure in anticoagulated patients. DDInteract may be accessed by clinicians to evaluate risk of harm from drug-drug interactions for patients on anticoagulants.

Group II: Standard of Care Active Control 1 Intervention

This population will consist in outpatient clinics who treat oral anticoagulated patients where DDInteract has not yet been implemented.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

A new decision aid (DA) tool for patients with atrial fibrillation (AF) has been developed to help them understand their specific risks for stroke and bleeding when considering oral anticoagulant (OAC) treatments, based on a comprehensive review of literature and patient feedback.

The tool integrates risk assessment modules and preference assessments to facilitate shared decision-making, aiming to empower patients to make informed choices about their treatment options, although further research is needed to test its effectiveness in real-world scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a shared decision-making tool to assist patients and clinicians with decisions on oral anticoagulant treatment for atrial fibrillation. Kaiser, K., Cheng, WY., Jensen, S., et al.[2018]

Citations

1. withpower.com withpower.com/trial/phase-anticoagulants-9-2023-11995

Decision-Making Tool for Blood Thinners (DDInteract Trial) DDInteract will enable shared-decision making using individually-tailored information on the potential benefits and harms of drug interactions in anticoagulated ...

2. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/implementation-ddinteract-shared-decision-making-tool-anticoagulant-drug-drug

Implementation of DDInteract: A Shared Decision Making Tool ... This research has the potential to reduce drug-drug interactions involving anticoagulants through a novel shared decision making tool that visually displays ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36260377/

Formative Evaluation of an Anticoagulant Drug Interaction Conclusions: Overall, DDInteract may improve encounters where there is a risk of bleeding due to a potential drug-drug interaction involving ...

4. formative.jmir.org formative.jmir.org/2022/10/e40018

Shared Decision-Making for Drug-Drug Interactions Conclusions: Overall, DDInteract may improve encounters where there is a risk of bleeding due to a potential drug-drug interaction involving ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8579222/

A Shared Decision-making Tool for Drug Interactions ... This study aims to design and study the usability of DDInteract, a tool to support shared decision-making (SDM) between a patient and provider for the DDI.